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510(k) Data Aggregation

    K Number
    K260177

    Validate with FDA (Live)

    Device Name
    Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1)
    Manufacturer
    Xenocor, Inc.
    Date Cleared
    2026-02-12

    (22 days)

    Product Code
    GCJ,GCQ,HET
    Regulation Number
    876.1500
    Type
    Special
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K220872
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Saberscope™ Laparoscope is intended to be used in diagnostic and therapeutic procedures for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs.

    Device Description

    The Saberscope™ Laparoscope device contains two separate functioning components. First is the single-use, sterile Saberscope™ Laparoscope Device, which includes a 0° camera on a 5 mm rigid shaft with a ± 90° articulating tip, 36 cm long shaft, and high-definition video image. The second is the Xenocor® VPU which converts the digital signal from the camera to HDMI signal for display onto the HD video screen for the surgeon to view.

    AI/ML Overview

    N/A

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